Today Paula Jardine starts a three-part investigation into the political decisions that allowed the experimental, gene therapy Covid ‘vaccines’ fast passage through the approval process. It follows on from her previous report, published two weeks ago, into the sleight of hand that won Covid vaccine approval for Pfizer.
In the first part, she exposes the UK’s highly questionable, indeed reckless, role in bouncing other regulators into rolling out unlicensed products by issuing ‘open-ended’ temporary use authorisations normally reserved for compassionate use and time-limited to one year.
ON December 2, 2020, nigh on a year ago, the UK Medicines and Healthcare products Regulatory Agency (MHRA), stole a march on regulators around the world, becoming the first to authorise supply of an ‘unlicensed but not untested’ pharmaceutical developed to prevent Covid-19, under an open-ended temporary use authorisation (TUA).
The product, BNT162b2, a gene transfer therapy, which was not assessed in Europe as an advanced medicine as per the normal requirements due to an opportunistic interpretation of a loosely-worded EU directive, was supplied for use as a next-generation vaccine.
MHRA made the decision after reviewing interim summary data submitted by the manufacturer 12 days prior, and without examining any of the raw data on the 36,000 trial participants.
On November 20, Pfizer/BioNTech applied to the US Food and Drug Administration (FDA) for an emergency use authorisation (EUA), and to the European Medicines Agency (EMA) for a conditional marketing authorisation. These are accelerated approvals processes that normally take six months.
MHRA, while still operating under EU law, opted to use the EMA’s temporary use authorisation, usually a last-resort mechanism allowing for compassionate use of experimental products.
The UK Department of Health and Social Care consultation into regulatory reforms, undertaken principally to protect suppliers and those administering Covid vaccines from civil liability, suggests that while TUA was an option offered to ministers, it was not the recommended one.
Taken by surprise at the news, the first reaction of Dr Anthony Fauci, Director of the US National Institute of Allergy and Infectious Diseases (NIAID), was to say: ‘If you go quickly and you do it superficially, people are not going to want to get vaccinated.’
But Professor Stephen Evans, statistician to the ‘Meta-Data Safety and Monitoring Board’ for CEPI, the Coalition for Epidemic Preparedness Innovations, said: ‘Dr Fauci has been and still is an extremely good scientist and his advice has been of very high quality throughout this pandemic. However, I think it is possible that he has overstated concerns about the UK assessment process for the Pfizer/BioNTech vaccine.’
A reduction in the MHRA’s overall workload had, said Evans, freed up resources, enabling the agency – which the head of the UK vaccine task force, Kate Bingham, said was universally known as an incredibly flexible and thoughtful regulator – to respond in a more timely fashion than other regulators.
The Wall Street Journal reported a Pfizer vice-president, Ralf Rene Reinert, praising the MHRA. The agency had asked for the same level of detail as all other regulators, as it had been responding quickly to new data throughout the rolling review process which had begun on October 6, sometimes in around ten minutes.
‘The MHRA has been extremely agile and responsive throughout the Covid pandemic,’ said Professor Derek Hill, an expert in medical imaging and devices. ‘Rapid decision in the Pfizer vaccine is the latest example. All the political statements about this being some triumph of the UK in coming “first in some race” is, however, unwise.
‘We must assume that the MHRA acted efficiently and diligently and free from any political interference, despite the tone of political announcements this morning. We will no doubt soon hear decisions from FDA and EMA on this vaccine.’
The news that the Pfizer/BioNTech vaccine was believed to have reached the necessary effective threshold was not entirely unexpected, advance notice having been made to the financial markets in the weeks leading up to it.
In early November 2020, Pfizer announced its first set of Phase III trials results, showing the vaccine had 90 per cent efficacy in trial participants without evidence of previous Sars-Cov2 infection.
It said research was ongoing to evaluate the vaccine’s potential to provide protection in people previously exposed to SARS-Cov-2 and its ability to prevent severe Covid-19 disease in the event of vaccine failure.
Eleven days later, when Pfizer applied for the EUA, it reported an even higher efficacy of 95 per cent. It now said its product not only prevented severe disease, it was also safe for people previously infected with Sars-Cov-2 virus. The trials were too short to assess how long the protection lasted.
Every effort was made along the way to reassure the public in advance of the authorisation. Responding to the first Pfizer announcement, Dr Heidi Larson, of the Bill and Melinda Gates Foundation (BMGF)-funded Vaccine Confidence Project, told the Guardian that the public had nothing to be concerned about.
‘There’s a lot of language out there about speed, but we haven’t really talked about why things are faster and it’s not because we’re shortcutting old processes,’ she said. ‘These new Covid vaccines are on brand new platforms. There’s never been an mRNA vaccine (which uses the genetic code rather than any part of the virus itself) before for humans. So, this Pfizer vaccine, for instance, would be absolutely brand new, made in a new way.’
By issuing the TUA, the UK pressed to go on one of the most ambitious and rapid vaccine rollouts in history. It soon got political. As Professor Hill predicted, other regulators began falling in behind.
President Trump summoned the head of the FDA to the White House for a meeting, the very day of the MHRA announcement. Under intense political pressure, the agency set up to protect consumers truncated its own accelerated review procedure – issuing an emergency use authorisation on December 11. A conditional marketing authorisation from the EMA followed ten days later.
The MHRA announcement marked a dramatic reversal in fortunes for an entire class of advanced gene therapy medicines. And as it did, a young American man, dead longer than he lived, may have stirred in his grave.
The promise of designer medicines that edit the human genome appeared stillborn following the death in 1999 of Jesse Gelsinger, an 18-year-old volunteer participating in the Phase I safety study of the first human trial of a gene therapy.
Gelsinger had a rare genetic disorder. A partially defective gene impaired the metabolisation of ammonia by his liver. When well managed with drugs and a low-protein diet, it wasn’t life-threatening to him, but he wanted to help others. A successful therapy promised to save the lives of baby boys with a fully defective version of the gene, who die within days of birth.
The babies themselves hadn’t been considered suitable participants by the ethics committee, as it was felt the parents would be unable to give true informed consent under such difficult circumstances.
A genetically modified adenovirus, the same platform used in the AstraZeneca Covid-19 vaccine, was infused directly into Gelsinger’s liver to deliver a normal version of the gene to its cells. The gene itself didn’t kill him, his body’s response to the adenovirus did.
Ninety-two hours after dosing with the infusion, Jesse died of Acute Respiratory Distress Syndrome (ARDS) as his immune system, thought to have been primed by prior exposure to an adenovirus, overreacted, causing multiple organs, including his lungs, to fail. An autopsy found the adenovirus had spread via his circulatory system into other organs, causing a catastrophic systemic immune response.
An investigation held in the wake of Gelsinger’s death raised questions over whether he had been properly and fully informed of the risks, or indeed whether he fully understood them when he volunteered.
A wider problem of under-reporting of adverse events in gene therapy trials was uncovered. They are proprietary information, commercially confidential, of course. The researchers were criticised for having financial conflicts of interest.
The legacy of Gelsinger’s premature death was the introduction of stricter safeguards for human experimentation into what regulators called ‘complex investigational products’. He might not have been helping others in the way he’d imagined, but Jesse’s death counted for something and it cast a long shadow.